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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K100152
Device Name SIRONA CAD/CAM SYSTEM
Applicant
SIRONA DENTAL SYSTEMS GMBH
FABRIKSTRASSE 31
BENSHEIM,  DE D-64625
Applicant Contact FRITZ KOLLE
Correspondent
SIRONA DENTAL SYSTEMS GMBH
FABRIKSTRASSE 31
BENSHEIM,  DE D-64625
Correspondent Contact FRITZ KOLLE
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/19/2010
Decision Date 10/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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